Clinical Trials Logo
  1. Home
  2. Allergic Asthma
  3. NCT05813470

Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma

Allergic Asthma Clinical Trial

Official title:
A Phase III, Randomized, Multicenter, Double-blind, Two-armed, Parallel, Active-controlled, Equivalency Clinical Trial to Compare Efficacy and Safety of Omalizumab (CinnaGen, Iran) in Comparison to Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland) in Patients With Uncontrolled Moderate to Severe Allergic Asthma

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Omalizumab produced by CinnaGen compared with Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland) in subjects with uncontrolled Moderate to Severe Allergic Asthma All the participants will receive one of the following regimens: Omalizumab (CinnaGen) or Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland), as subcutaneous injections, Omalizumab was administered every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg/IgE for a duration of 28 weeks The primary objective of this study is to assess whether the efficacy of Omalizumab (CinnaGen, Iran) is equivalent to Xolair® (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) as measured by rate of protocol-defined asthma exacerbations during the 28-week treatment period

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05813470
Study type Interventional
Source Cinnagen
Contact
Status Completed
Phase Phase 3
Start date January 18, 2021
Completion date January 15, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT03850626 - Validation of Combined Symptom Medication Score (cSMS) in Allergic Patients
Completed NCT02911688 - Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure Phase 2
Active, not recruiting NCT01776177 - The REALITY Study - a Real-life Long-term Analysis of Xolair Therapy N/A
Completed NCT00485576 - Safety and Efficacy Study of Eculizumab in Patients With Mild Allergic Asthma Phase 2
Completed NCT00736801 - Effect of Salmeterol on Brain-Derived Neurotrophic Factor (BDNF) Concentrations in Asthma N/A
Completed NCT00515775 - Influence of a Inhaled Corticosteroid Therapy Versus Corticosteroid + LABA Therapy on the FeNO of Asthmatic Children N/A
Completed NCT04259164 - Anti-inflammatory Effects Glycopyrronium Phase 3
Active, not recruiting NCT04619017 - Airway Immune Response to Allergens (Use Lay Language Here) Phase 1
Completed NCT01699594 - Change in Airway Responsiveness After Allergen Exposure N/A
Completed NCT00999466 - The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen Phase 2
Completed NCT01353755 - 2nd Pivotal Study rPhleum - Adults and Adolescents With Rhinoconjunctivitis +/-Controlled Asthma Phase 3
Completed NCT00434434 - A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma Phase 2
Completed NCT00492076 - Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma Phase 4
Completed NCT00829179 - Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma Phase 3
Completed NCT00490425 - Prevention of Asthma and Allergy by Probiotic Lactobacillus GG Phase 4
Recruiting NCT04542902 - Non-coding RNAs Analysis of Eosinophil Subtypes in Asthma N/A
Recruiting NCT04109534 - Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma N/A
Active, not recruiting NCT05186025 - Tyrosine Allergoid Paediatric and Adult Study
Withdrawn NCT03307278 - House Dust Mite Induced Inflammasome Activation on Corticosteroid Resistance N/A
Enrolling by invitation NCT06151938 - Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis